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Upgrade Program Implementation at Colorrectal Surgery and Complications: Early Diagnosis

NCT ID: NCT04632446

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-15

Study Completion Date

2022-12-31

Brief Summary

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The anastomotic leak (AL) is a very serious complication in colorectal surgery not only because of its severity but its frequency. Other facet for study, besides the risk factor and prevention, is the AL early diagnostic, due to minimize the clinical consequences and severity; and avoid the failure-to-recue. Several studies analyze the Creactive protein (CRP) and Procalcitonine (PCT) usefulness in AL predictor before the clinical signs appear.

At a prospective observational study carry on our center, it concluded that CRP at 3rd day after surgery over 15mg/dl was a very important AL predictor, even before the clinical changes appear. The aim of this study is minimize the severity complications and the mortality due to AL appears. The aim of this study is minimize the severity complications and the mortality due to AL by means of introduces an upgrade program in which a CT scan will be conduct in all the patients with high CRP levels at 3rd, 4th or 5th postoperative day, with the goal to know the AL early and make all the therapeutic step to minimize the consequences.

Detailed Description

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Conditions

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Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Early diagnosis

Early diagnosis. Upgrade program implementation.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years of age.
* Patients undergoing elective colorectal surgery due to neoplastic or non-neoplastic etiology.
* Patients with an anastomosis performed in the surgical act.
* Signed informed consent.

Exclusion Criteria

* Patients who require transfer to another center.
* Patients with fatal evolution: those who require urgent reoperation for an inarverted perforation, early leakage of anastomosis or death before the third postoperative day.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Graciela Valero-Navarro, MD

Role: PRINCIPAL_INVESTIGATOR

- Hospital Morales Meseguer

Locations

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- Hospital Morales Meseguer

Murcia, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Graciela Valero-Navarro, MD

Role: CONTACT

Phone: 968360900

Email: [email protected]

Facility Contacts

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Graciela Valero-Navarro, MD

Role: primary

References

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Baeza-Murcia M, Valero-Navarro G, Pellicer-Franco E, Soria-Aledo V, Mengual-Ballester M, Garcia-Marin JA, Betoret-Benavente L, Aguayo-Albasini JL. Early diagnosis of anastomotic leakage in colorectal surgery: prospective observational study of the utility of inflammatory markers and determination of pathological levels. Updates Surg. 2021 Dec;73(6):2103-2111. doi: 10.1007/s13304-021-01082-8. Epub 2021 May 20.

Reference Type DERIVED
PMID: 34018141 (View on PubMed)

Other Identifiers

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IMIB-2020-UPCS

Identifier Type: -

Identifier Source: org_study_id